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Peanut Allergen Powder

Medically reviewed by Drugs.com. Last updated on Apr 29, 2021.

Pronunciation

(pee nut AL er jen pow der)

Index Terms

  • Peanut (Arachis hypogaea) Allergen Powder-dnfp

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Sprinkle Capsule, Oral:

Palforzia: 0.5 mg, 1 mg, 10 mg, 20 mg, 100 mg

Sprinkle Packet, Oral:

Palforzia: 300 mg

Brand Names: U.S.

  • Palforzia

Pharmacologic Category

  • Allergen-Specific Immunotherapy

Pharmacology

Not established.

Use: Labeled Indications

Peanut allergy: Oral immunotherapy for mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut in patients with a confirmed diagnosis of peanut allergy. Initial dose escalation may be administered to patients 4 to 17 years of age. Up-dosing and maintenance may be continued in patients ≥4 years of age. Peanut allergen powder is to be used in conjunction with a peanut-avoidant diet.

Limitation of use: Not indicated for the emergency treatment of allergic reactions, including anaphylaxis.

Contraindications

Uncontrolled asthma; history of eosinophilic esophagitis and other eosinophilic GI disease.

Dosing: Adult

Note: Injectable epinephrine must be available during treatment. Do not initiate treatment in patients who experienced severe or life-threatening anaphylaxis in the last 60 days. Patients must continue to maintain a peanut-avoidant diet.

Peanut allergy immunotherapy: Oral: Treatment is administered in 3 phases:

Initial dose escalation phase: Refer to pediatric dosing.

Up-dosing phase:

Note: Up-dosing should begin the day after completion of the initial dose escalation phase or within 4 days; if not started within 4 days, the initial dose escalation phase must be repeated. The first dose of each up-dose must be administered under the direct supervision of a health care provider and the patient should be observed for ≥60 minutes. Administer subsequent doses at the same dose level once daily, preferably in the evening. Do not progress dose more frequently than 2-week intervals; do not omit any dose levels.

Daily Dosing for Up-Dosing Phase

Dose Level

Dose

Duration

1

3 mg

2 weeks

2

6 mg

2 weeks

3

12 mg

2 weeks

4

20 mg

2 weeks

5

40 mg

2 weeks

6

80 mg

2 weeks

7

120 mg

2 weeks

8

160 mg

2 weeks

9

200 mg

2 weeks

10

240 mg

2 weeks

11

300 mg

2 weeks

Dose modification: Allergic reactions, including GI reactions, that are severe, recurrent, bothersome, or last >90 minutes may require dose adjustments. Based on clinical judgement, may maintain dose level for >2 weeks, reduce dose, withhold dose, or discontinue therapy. Dose modifications may also be necessary for missed doses or patient convenience. Dose modification should not be attempted during initial dose escalation phase.

Maintenance dosing phase: Note: Initial dose escalation phase and up-dosing phase should be completed prior to maintenance dosing: 300 mg once daily.

Dose modification: Allergic reactions, including GI reactions, that are severe, recurrent, bothersome, or last >90 minutes may require dose adjustments. Based on clinical judgement, may reduce dose, withhold dose, or discontinue therapy. Dose modification should not be attempted during initial dose escalation phase.

Missed doses:

Missed 1 to 2 consecutive days: Resume dose at same dose level.

Missed ≥3 consecutive days: Has not been studied. Contact health care provider; resuming dose should only be done under direct supervision of health care provider.

Discontinuation of therapy: Discontinue therapy in patients who are unable to tolerate initial doses up to 3 mg during initial dose escalation phase, patients with suspected eosinophilic esophagitis, patients unable to comply with daily dosing, or patients with recurrent asthma exacerbations or persistent loss of asthma control.

Dosing: Pediatric

Note: Injectable epinephrine must be available during treatment. Do not initiate treatment in patients who experienced severe or life-threatening anaphylaxis in the last 60 days. Patients must continue to maintain a peanut-avoidant diet.

Peanut allergy immunotherapy: Treatment is administered in 3 phases:

Initial dose escalation phase: Note: Initial dose escalation is to be completed on a single day under the direct supervision of a certified health care provider able to manage severe allergic reactions. Doses should not be modified during this phase.

Children ≥4 years and Adolescents ≤17 years: Oral:

Note: Observe patient for 20 to 30 minutes between each dose level and for 60 minutes after last dose of phase.

Initial Dose Escalation Phase

Dose Level

Dose

A

0.5 mg

B

1 mg

C

1.5 mg

D

3 mg

E

6 mg

Up-dosing phase: Children ≥4 years and Adolescents: Oral:

Note: Up-dosing should begin the day after initial dose escalation phase or within 4 days; if not started within 4 days, the initial dose escalation phase must be repeated. The first dose of each up-dose should be administered under the direct supervision of a health care provider and the patient should be observed for at least 60 minutes. Administer subsequent doses at the dose level once daily preferably in the evening. Do not progress dose more frequently than at 2-week intervals; do not omit any dose levels.

Daily Dosing for Up-Dosing Phase

Dose Level

Dose

Duration

1

3 mg

2 weeks

2

6 mg

2 weeks

3

12 mg

2 weeks

4

20 mg

2 weeks

5

40 mg

2 weeks

6

80 mg

2 weeks

7

120 mg

2 weeks

8

160 mg

2 weeks

9

200 mg

2 weeks

10

240 mg

2 weeks

11

300 mg

2 weeks

Dose modification: Allergic reactions, including GI reactions, that are severe, recurrent, bothersome, or last longer than 90 minutes may require dose adjustments. Based on clinical judgement, may maintain dose level for longer than 2 weeks, reduce dose, withhold dose, or discontinue therapy. Dose modifications may also be necessary for missed doses or patient convenience. Dose modification should not be attempted during initial dose escalation phase.

Maintenance dosing phase: Note: Initial dose escalation phase and up-dosing phase should be completed prior to maintenance dosing.

Children ≥4 years and Adolescents: Oral: 300 mg once daily.

Dose modification: Allergic reactions, including GI reactions, that are severe, recurrent, bothersome, or last longer than 90 minutes may require dose adjustments. Based on clinical judgement, may reduce dose, withhold dose, or discontinue therapy. Dose modification should not be attempted during initial dose escalation phase.

Missed doses:

Missed 1 to 2 consecutive days: Resume dose at same dose level.

Missed ≥3 consecutive days: Has not been studied, contact health care provider; resuming dose should only be done under direct supervision of health care provider.

Discontinuation of therapy: Discontinue therapy in patients who are unable to tolerate initial doses up to 3 mg during initial dose escalation phase, patients with suspected eosinophilic esophagitis, patients unable to comply with daily dosing, or in patients with recurrent asthma exacerbations or persistent loss of asthma control.

Administration

Oral: For oral use only. Do not swallow capsule or inhale powder. Open capsule or sachet and empty the entire dose of peanut allergen powder onto a few spoonfuls of refrigerated or room temperature semisolid food (eg, applesauce, yogurt, pudding); mix well; do not use liquid to prepare. Consume the entire volume of prepared mixture promptly. Dispose of opened capsule or sachet and all unused peanut allergen powder. Wash hands immediately after handling capsule or sachet. Auto-injectable epinephrine must be available to patients at all times.

Storage

Store at 2°C to 8°C (36°F to 46°F). Do not freeze. Store in the original packaging until use to protect from moisture.

Drug Interactions

There are no known significant interactions.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%:

Dermatologic: Pruritus (8% to 33%), urticaria (4% to 28%)

Gastrointestinal: Abdominal pain (26% to 67% [placebo: 8% to 35%]), nausea (9% to 32% [placebo: 0.7% to 14%]), oral paresthesia (2% to 14% [placebo: 2% to 4%]), vomiting (3% to 37% [placebo: 0.7% to 16%])

Local: Local pruritus (oral: 9% to 31% [placebo: 3% to 10%])

Respiratory: Cough (3% to 32%), pharyngeal edema (3% to 14%), rhinorrhea (1% to 21%), sneezing (3% to 20%), throat irritation (9% to 40%), wheezing (≤12%)

1% to 10%:

Dermatologic: Pruritus of ear (≤6%)

Gastrointestinal: Eosinophilic esophagitis (1% [placebo: 0%])

Hypersensitivity: Anaphylaxis (≤9% [placebo: 0.3% to 4%])

Respiratory: Dyspnea (≤8%)

ALERT: U.S. Boxed Warning

Anaphylaxis

Peanut allergen powder can cause anaphylaxis, which may be life-threatening and can occur at any time during therapy. Prescribe injectable epinephrine, instruct and train patients on its appropriate use, and instruct patients to seek immediate medical care upon its use. Do not administer peanut allergen powder to patients with uncontrolled asthma. Dose modifications may be necessary following an anaphylactic reaction. Observe patients during and after administration of the initial dose escalation and the first dose of each up-dosing level, for at least 60 minutes. Because of the risk of anaphylaxis, peanut allergen powder is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Palforzia REMS.

Warnings/Precautions

Concerns related to adverse effects:

• Anaphylaxis: [US Boxed Warning]: Peanut allergen powder can cause anaphylaxis, which may be life threatening and can occur at any time during therapy. Dose modifications may be necessary following an anaphylactic reaction. Observe patients during and after administration of the initial dose escalation and the first dose of each up-dosing level for ≥60 minutes. Anaphylaxis most commonly occurs within 2 hours after a dose but may be delayed for >10 hours in some patients. Do not initiate therapy in patients who have had severe or life-threatening anaphylaxis in the previous 60 days. Increased risk of anaphylaxis may occur with potential cofactors, including exercise, hot water exposure, illness, fasting, menstruation, sleep deprivation, nonsteroidal anti-inflammatory drug use, or uncontrolled asthma; if possible, adjust dosing time to avoid cofactors or temporarily discontinue therapy.

• Esophagitis: Eosinophilic esophagitis has been reported. Discontinue therapy in patients who experience severe or persistent GI symptoms (eg, dysphagia, vomiting, nausea, gastroesophageal reflux disease, chest pain, abdominal pain). Use is contraindicated in patients with a history of eosinophilic esophagitis.

• GI effects: GI adverse reactions (including abdominal pain, vomiting, nausea, oral pruritus, and oral paresthesia) have been reported; dose adjustment may be necessary.

Disease-related concerns:

• Respiratory disease: [US Boxed Warning]: Do not administer to patients with uncontrolled asthma. Uncontrolled asthma is a risk factor for serious outcome in anaphylaxis, including death. Withhold treatment if patient is experiencing an acute asthma exacerbation; resume therapy with caution after resolution of exacerbation. Reevaluate patients with recurrent asthma exacerbations and consider discontinuation. Use has not been studied in patients with severe asthma, persistently uncontrolled asthma, or in patients on long-term systemic corticosteroid therapy. Use is contraindicated in patients with uncontrolled asthma.

Other warnings/precautions:

• Administration: [US Boxed Warning]: Prescribe injectable epinephrine, instruct and train patients on its appropriate use, and instruct patients to seek immediate medical care upon its use.

• Appropriate patient selection: Use may not be suitable for patients with conditions that may reduce their ability to survive anaphylaxis, including but not limited to compromised lung function, severe mast cell disorder, or cardiovascular disease.

• Appropriate use: Discontinue use in patients who are unable to comply with the daily dosing requirements. Use may not be suitable for patients taking medications that can inhibit or potentiate the effects of epinephrine.

• REMS: [US Boxed Warning]: Because of the risk of anaphylaxis, peanut allergen powder is available only through a restricted program under a REMS called the Palforzia REMS.

Monitoring Parameters

Signs/symptoms of adverse reactions; monitor for ≥60 minutes after the last dose of the initial dose escalation and after the first dose of each new up-dosing level.

Pregnancy Considerations

Accidental exposure to peanuts in a peanut allergic woman may cause anaphylaxis, which may then decrease maternal BP and placental perfusion. Anaphylaxis may also occur following exposure to peanut allergen powder. Pregnant women were excluded from initial studies of peanut allergen powder as oral immunotherapy (PALISADE Group [Vickery 2018]). In general, immunotherapy should not be initiated during pregnancy (Pitsios 2019). Data collection to monitor pregnancy and infant outcomes following exposure to peanut allergen powder is ongoing. Health care providers are encouraged to enroll females exposed to peanut allergen powder during pregnancy in the pregnancy registry (1-833-246-2566).

Patient Education

What is this drug used for?

• It is used to help with allergies caused by peanuts. This drug is not for use to treat an allergic reaction.

Frequently reported side effects of this drug:

• Abdominal pain

• Nausea

• Vomiting

• Ear itching

• Mouth itching

• Tongue itching

• Mouth numbness

• Mouth tingling

• Throat irritation

• Cough

• Runny nose

• Sneezing

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Trouble swallowing

• Trouble speaking

• Painful swallowing

• Heartburn

• Chest pain

• Fast heartbeat

• Passing out

• Passing out

• Dizziness

• Flushing

• Shortness of breath

• Severe diarrhea

• Abdominal cramps

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.